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Christine Anggun Putri, Fahd Quhill; 36-months real-world experience in patients with refractory chronic diabetic macular edema (DME) treated with the 190 micrograms fluocinolone acetonide intravitreal implant (ILUVIEN).. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4844.
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The ILUVIEN implant releases 0.2 µg of fluocinolone acetonide per day for up to 3 years. In the United Kingdom, it is licensed for the treatment of chronic DME in pseudophakic patients who have had suboptimal response to prior treatment. As Iluvien is increasingly being used, it is important to evaluate its long-term clinical efficacy and safety. We performed a retrospective, observational study to assess the changes in best recorded visual acuity (BRVA; ETDRS letters), changes in central retinal thickness (CRT), additional treatment required, and safety profile over 36 months of treatment.
A retrospective review of electronic medical records was conducted on all patients treated with ILUVIEN for DME that had at least 36-months follow up in a tertiary centre in UK.
26 patient eyes (n=26) were identified with an average age of 68 ± 10 years (mean ± SD) and diabetes duration of 20.4 ± 11.8 years.At year 3, mean BRVA increased by 8.2 ± 20.2 letters from a baseline of 40.1 ± 21.4 letters, accompanied by a reduction in CRT of 175 ± 209µm from a baseline of 568 ± 164µm. 88.5% of patients maintained or gained vision, 57.7% gained ≥5 letters, 42.3% gained ≥10 letters, and 34.6% gained ≥15 letters.Average number of anti-VEGF injections 3 years pre-Iluvien (n=21; 80.8%) and post-Iluvien (n=10; 38.5%) were 7.7 ± 3.5 and 2.9 ± 4.1 respectively. Average number of macular laser performed 3 years pre-Iluvien (n=11; 42.3%) and post-Iluvien (n=3; 11.5%) were 1.1 ± 0.6 and 0.4 ± 0.9 respectively.Regarding safety, 50% experienced a raise in intraocular pressure (IOP) of ≥21.0 mmHg, 34.6% of patients required a new or a change in IOP-lowering drops, with one patient (3.8%) requiring trabeculectomy. Amongst these patients with raised IOP, there was an increase of 16.4 ± 10.9 mmHg from baseline of 17.0 ± 5.1 mmHg.
This real-world data shows significant visual and anatomical improvement maintained at 3 years after initial ILUVIEN injection. These results are similar to those reported in the FAME trials. Iluvien reduces the numbers of additional anti-VEGF or macular laser required. IOP should be monitored regularly and appears to be a manageable side effect with medical therapy in the vast majority of cases.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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